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Neuromodulation and Fatigue

Primary Purpose

Healthy Aging, Fatigue

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
electrical stimulation
Sponsored by
University of Oklahoma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Healthy Aging focused on measuring Transcutaneous spinal direct current stimulation, TsDCS, Fatigability

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Healthy individuals between 18 and 50 years old

Exclusion Criteria:

Metal implants or joint replacement. Presence of neuromuscular disease. Skin hypersensitivity.

Sites / Locations

  • University of Oklahoma

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Men

Women

Arm Description

Individuals will participate in 1 familiarization and 3 test sessions

Individuals will participate in 1 familiarization and 3 test sessions

Outcomes

Primary Outcome Measures

Force
Change in force will be evaluated with a device during each test session
Perception of effort
Change in perceived effort will be evaluated with visual analogue scales
Muscle activation
Electromyography will be used to quantify muscle activation

Secondary Outcome Measures

Full Information

First Posted
August 2, 2022
Last Updated
November 7, 2022
Sponsor
University of Oklahoma
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1. Study Identification

Unique Protocol Identification Number
NCT05487131
Brief Title
Neuromodulation and Fatigue
Official Title
Neuromodulation and Fatigue
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 9, 2023 (Anticipated)
Primary Completion Date
September 29, 2024 (Anticipated)
Study Completion Date
December 29, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oklahoma

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
In this project, we aim to determine any potential effects of a weak electrical current applied to the neck or thoracic area on functional capacity and muscle activation. Healthy individuals will participate in one familiarization followed by three experimental sessions. Fatigability and motor function will be assessed in each test session.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Aging, Fatigue
Keywords
Transcutaneous spinal direct current stimulation, TsDCS, Fatigability

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Men
Arm Type
Experimental
Arm Description
Individuals will participate in 1 familiarization and 3 test sessions
Arm Title
Women
Arm Type
Experimental
Arm Description
Individuals will participate in 1 familiarization and 3 test sessions
Intervention Type
Behavioral
Intervention Name(s)
electrical stimulation
Intervention Description
different types of weak electrical stimulation will be used
Primary Outcome Measure Information:
Title
Force
Description
Change in force will be evaluated with a device during each test session
Time Frame
Each session will take approximately 2 hours (total of 4 test sessions)
Title
Perception of effort
Description
Change in perceived effort will be evaluated with visual analogue scales
Time Frame
Each session will take approximately 2 hours (total of 4 test sessions)
Title
Muscle activation
Description
Electromyography will be used to quantify muscle activation
Time Frame
Each session will take approximately 2 hours (total of 4 test sessions)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy individuals between 18 and 50 years old Exclusion Criteria: Metal implants or joint replacement. Presence of neuromuscular disease. Skin hypersensitivity.
Facility Information:
Facility Name
University of Oklahoma
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73071
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Neuromodulation and Fatigue

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